Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 622-542-2 | CAS number: 3891-98-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,6,10-trimethyldodecane
- EC Number:
- 622-542-2
- Cas Number:
- 3891-98-3
- Molecular formula:
- C15H32
- IUPAC Name:
- 2,6,10-trimethyldodecane
- Test material form:
- other: liquid
- Details on test material:
- Farnesane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA on 06/09/10 & 07/07/10.
- Age at study initiation: The animals were born on 02/20/10 & 03/13/10. Experimental Start date was 8/17/10
- Weight at study initiation: The pretest body weight range was 3.0 - 3.4 kg.
- Housing: The animals were identified by cage notation and a uniquely numbered metal eartag and individually housed in suspended wire bottom cages. Paper bedding was placed beneath the cages and changed at least three times/week. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) was provided daily
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: None specified
IN-LIFE DATES: From: 8/17/10 To: 8/24/10
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site was approximately 10 x 10 cm and remained intact.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): Neat - Duration of treatment / exposure:
- The test article was kept in contact with the skin for 4 hours at which time the wrappings and patches were removed. Residual test article was removed from the test site by gently washing with distilled water at the end of the exposure period, prior to scoring for dermal reactions.
- Observation period:
- The test sites were scored for dermal irritation at 60 minutes and at 24, 48 and 72 hours in all animals and on day 7 in one animal following patch removal. Body weights were recorded pretest and at termination.
Animals were observed for toxicological and pharmacological effects at each dermal observation period and observed for mortality daily. All animals were humanely sacrificed using CO2 following study termination. - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
-The test article was dosed by volume, 0.5 ml/site. The test article was placed over a 2 x 3 cm gauze patch. Gentle pressure was applied to aid in the distribution of the test article over the prepared site. The patch was secured with non-irritating tape. The torso was covered with a piece of porous dressing (semi-occlusive) large enough to cover the dose site with at least 5 cm square to spare on all sides of the gauze patch. Porous, non-irritating tape was used to encircle the trunk of the animal. The test article was kept in contact with the skin for 4 hours at which time the wrappings and patches were removed. Residual test article was removed from the test site by gently washing with distilled water at the end of the exposure period, prior to scoring for dermal reactions.
SCORING SYSTEM:
Erythema & Eschar
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1.0 mm) 3
Severe edema (raised more than 1.0 mm, extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- At one hour following the 4 hour exposure, erythema was very slight to well defined and edema was very slight. At 24 hours, erythema was very slight to well defined and edema was absent to very slight. At 48 hours, erythema was absent to very slight and edema was absent. At 72 hours, erythema was absent to very slight (one animal) and edema was absent. Animal #H3487/M was extended to day 7. No erythema or edema was noted.
Dermal Observations, Body Weights and Systemic Observations
===============================================================================
Rabbit Eartag: H3490 H3427 H3487
Sex: M M M
Pretest Body Weight - kg: 3.4 3.0 3.1
Terminal Body Weight Day 7 - kg: 3.4 3.1 3.2
Time after patch removal Erythema & Eschar Formation
60 minutes 1 2 2
24 hours 1 2 2
48 hours 0 1 1
72 hours 0 1 0
7 days N/A 0 N/A
Edema
60 minutes 1 1 1
24 hours 0 1 0
48 hours 0 0 0
72 hours 0 0 0
7 days N/A 0 N/A
Systemic Observations
60 minutes A A A
24 hours A A A
48 hours A A A
72 hours A A A
N = Normal; N/A = Not applicable - Other effects:
- There were no abnormal physical signs noted during the observation period.
All body weight changes were normal
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Test material was not irritating per the EU CLP criteria
- Executive summary:
Objective: To determine the irritant or corrosive effects, if any, of test article when applied dermally. This study was designed to comply with the standards set forth in EPA Health Effects Testing Guidelines, OPPTS Series 870.2500, final guideline, August 1998.
Method Synopsis: Since the test article was not expected to produce severe irritation or corrosion, three healthy New Zealand White rabbits (males) were dosed dermally with farnesane.
The test article (0.5ml) was applied dermally to one intact site/rabbit. The test article was kept in contact with the skin for 4 hours at which time the wrappings were removed. Erythema and edema were scored at 60 minutes and at 24, 48 and 72 hours in all animals and on day 7 in one animal (H3487/M) following patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Animals were observed for toxicological and pharmacological effects at each dermal observation period and observed for mortality daily. Body weights were recorded pretest and at termination.
Summary: At one hour following the 4 hour exposure, erythema was very slight to well defined and edema was very slight. At 24 hours, erythema was very slight to well defined and edema was absent to very slight. At 48 hours, erythema was absent to very slight and edema was absent. At 72 hours, erythema was absent to very slight (one animal) and edema was absent. Animal #H3487/M was extended to day 7. No erythema or edema was noted.
There were no abnormal physical signs noted during the observation period. All body weight changes were normal.
Conclusion: Farnesane is not classfied as a dermal irritant according to CLP criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.